Kornimate/medical-research-clean huggingface dataset:
nitrocamptothecin in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.

objectives: i. assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma. outline: patients are stratified according to disease (choroidal vs nonchoroidal). patients receive oral nitrocamptothecin daily on days 1-5. treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic melanoma choroidal (no prior chemotherapy required) or nonchoroidal no more than 3 chemotherapy regimens bidimensionally measurable disease no symptomatic uncontrolled cns involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis not eligible for treatment protocol of higher priority patient characteristics: age: over 16 performance status: zubrod 0-2 life expectancy: greater than 8 weeks hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) transaminase no greater than 3 times uln renal: creatinine no greater than 2.0 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for 1 year after study no serious concurrent illness prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 3 weeks since prior chemotherapy and recovered endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: not specified

Keywords: stage iv melanoma recurrent melanoma
paclitaxel, carboplatin, and topotecan in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine whether the triple combination of carboplatin, paclitaxel and topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of carboplatin and paclitaxel.

carboplatin-paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. one option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. in two separate, single center phase ii studies, a different combination of the three active agents (carboplatin, paclitaxel and topotecan) has been tested. in these studies, carboplatin and paclitaxel were given at standard doses and schedules, followed sequentially by topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. the prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good. study hypothesis/comparison: the triple combination (carboplatin/paclitaxel/topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of carboplatin + paclitaxel

Eligibility criteria:
inclusion criteria: * histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary * international federation of gynecology and obstetrics (figo) stage iib-iv, regardless of measurable or non-measurable disease * no prior chemo- or radiotherapy * adequate hematologic, renal and hepatic function: * anc ≥ 1.5 x 10\^9/l, * platelet counts ≥ 100 x 10\^9/l, * total bilirubin ≤ 1.5 x upper normal limit, * alkaline phosphatase ≤ 3 x upper normal limit, * serum creatinine ≤ 1.25 upper normal limit, * estimated gfr ≥ 60 ml/min * performance status 0-2 (ecog) * life expectancy must be greater than 12 weeks exclusion criteria: * non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed mullerian tumors) or tumors of low malignant potential (borderline tumors) * prior treatment with chemo- or radiotherapy * administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy * history of congestive heart failure * symptomatic brain metastasis * complete bowel obstruction * dementia * active infection or other serious underlying medical condition * pre-existing motor or sensory neurologic pathology

Keywords: ovarian cancer first-line topotecan
ripretinib (qinlock®) according to current smpc

Conditions: GIST - Gastrointestinal Stromal Tumor

Summary: the goal of this prospective, observational study interest is to collect real-world data on ripretinib treatment in a broad patient population in germany. ripretinib will be administered according to the current smpc. thus, interest will evaluate for the first time ripretinib in gist patients in a real-world setting in germany. the main questions the study aims to answer are: * evaluate quality of live (qol) using the questionnaire eq-5d-5l to gain knowledge about how ripretinib treatment affects gist patients' well-being (change compared to baseline, time to deterioration) * assessment of effectiveness in routine treatment (progression-free survival, overall survival, best response, overall response rate, disease control rate * assessment of drug safety * assessment of parameters of physicians\&#39; treatment decision making * description of treatment reality in detail


Eligibility criteria:
inclusion criteria: patient is eligible if all criteria are met: * aged 18 years or older. * histologically confirmed advanced gist. * patients must have received prior treatment with three or more kinase inhibitors, including imatinib. * decision for treatment with ripretinib as per current smpc. * signed written informed consent \* patients are allowed to be enrolled up to 6 weeks after their first dose of ripretinib. patients with signed written informed consent after start of ripretinib treatment are not participating in the pro assessments. * willingness and capability to participate in patient-reported outcome (pro) assessment in german language. * other criteria according to current smpc. exclusion criteria: * participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial except for the follow-up period. * patients unable to consent. * other contraindications according to current smpc.

Keywords: advanced
efficacy and safety evaluation of pd1-bcma-cart

Conditions: Multiple Myeloma

Summary: this trial aims to evaluate the safety and efficacy of pd1-bcma-cart in treating patients with relapsed or refractory multiple myeloma.

using gene editing, chimeric antigen receptors recognizing bcma were integrated into subject self-derived t cells to obtain a large number of bcma-cart by in vitro amplification, and bcma-cart back into the subjects could identify and kill myeloma cells in the subjects.this open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of pd1-bcma-cart in the treatment of relapsed or refractory multiple myeloma.

Eligibility criteria:
inclusion criteria: * have the capacity to give informed consent; * confirmed diagnosis of active mm as defined by nccn and imwg criteria; * have a diagnosis of bcma+ multiple myeloma (mm), (≥ 5% bcma+ in cd138+ plasma cells by flow cytometry obtained within 45 days of study enrollment); * refractory and relapsed mm patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (asct); * ecog score=0-2. * subjects according with any of the following options: * age≥50; * failure with separation of t cells during autologous cart processing; or, * failure with expansion of autologous cart; or, * the proportion of t cells in pbmc \<10%; or, * won't benefit from autologous cart therapy because of disease progress. exclusion criteria: * pregnant or nursing women; women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy * active infection, hiv infection, syphilis serology reaction positive; * active hepatitis b, hepatitis c at the time of screening * significant hepatic dysfunction as following, sgot(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dl; * lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis * serious mental disorder; * with severe cardiac, liver, renal insufficiency, diabetes and other diseases; * participate in other clinical research in the past three months; previously treatment with any gene therapy products * contraindication to cyclophosphamide or fludarabine chemotherapy
pharmacology of insulin injected with jet-injection

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.


Eligibility criteria:
inclusion criteria: * age 18-50 years * body-mass index 18-28 kg/m2 * blood pressure \<160/90 mmhg * stable glycaemic control with hba1c 6.5-9.0% (for patients with type 1 diabetes mellitus) * duration of diabetes \>1 year (for patients with type 1 diabetes mellitus) exclusion criteria: * inability to provide informed consent * chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months) * chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb) treatment (for patients with type 1 diabetes mellitus) * type 2 diabetes in first-degree relatives (for healthy subjects) * history of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) * pregnancy * macroalbuminuria, i.e. urinary albumin excretion \>200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio \>300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus) * symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus) * proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)

Keywords: pharmacokinetic profile pharmacodynamic profile insulin jet injector
study of perennial allergic rhinitis

Conditions: Rhinitis, Allergic, Seasonal

Summary: this study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. perennial allergic rhinitis is triggered by house dust, mite and mold etc. typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.


Eligibility criteria:
inclusion criteria: * informed consent. * outpatient. * diagnosis of perennial allergic rhinitis with symptoms. * able to comply with study procedures. exclusion criteria: * significant concomitant medical condition. * use of corticosteroids/allergy medications. * laboratory abnormality. * positive pregnancy test.

Keywords: perennial allergic rhinitis
study of the duration and efficacy of mydayis on adult adhd symptoms and executive function throughout the day into the early evening

Conditions: Attention Deficit-Hyperactivity

Summary: attention-deficit/hyperactivity disorder (adhd) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.this is an outpatient study for subjects between the ages of 18-60, who have an attention deficit hyperactivity disorder (adhd) diagnosis meeting all inclusion criteria and not meeting any of the exclusion criteria.

one purpose of this trial is to extend the evidence basis for mydayis in adult adhd to include efficacy with a clinical adhd symptom measure validated for dsm-5 adult adhd. another purpose of this trial is to re-examine the clinical efficacy of mydayis later in the day on adhd symptoms; the data on adhd symptoms via the tass 1 (spencer et al. 2008) is a decade old and has not been examined in subsequent trials.

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18-60 of all races and ethnicity. * meets dsm v-tr criteria for a primary diagnosis of adhd (including predominantly inattentive presentation, or combined presentation) as diagnosed via the adult adhd clinician diagnostic scale version 1.2 (acds v1.2) exclusion criteria: * meets dsm v-tr criteria for a primary diagnosis of hyperactive-impulsive type adhd as diagnosed via the acds v1.2. * any other current psychiatric disorder, determined via the m.i.n.i, which requires pharmacotherapy treatment. * current suicidal ideation or history of suicide attempts, based on the columbia- suicide severity rating scale(c-ssrs) * lifetime history of bipolar disorder or any psychotic disorder as per the m.i.n.i * pregnant, breastfeeding or women planning to become pregnant. * positive urine drug toxicology are excluded. * any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
endovascular repair of abdominal aortic aneurysms

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of this study is to determine if it is safe and effective to use the talent aaa stent graft system as a treatment for aaas in patients who are also candidates for conventional surgical aneurysm repair.


Eligibility criteria:
inclusion criteria:1. patient has one of the following: * aneurysm \>4 cm in diameter, or an aneurysm that has increased in size by 0.5 cm in the last 6-months * aneurysm is 1.5 times larger than the diameter of the normal infrarenal aorta or symptomatic * aneurysm is saccular * penetrating ulcer 2. patient's vascular dimensions must be in the range that can be safely treated with the stent graft available to the physician at the time of the procedure. 3. patient has endovascular access to the aneurysmal site with the introducer sheath or delivery catheter of the appropriate ize device chosen for treatment. 4. patient has anatomic characteristics suitable for endovascular repair. 5. patient has an immediate life-threatening disease of the abdominal aorta in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment. 6. patient is american society of anesthesiology (asa) grade 1 through 4. 7. patient is able and willing to comply with 3 month, 6 month, 1 year and every year thereafter post treatment follow-up requirements. 8. patient or patient's legal representative understands and has signed an informed consent.\&#xa; exclusion criteria:1. patient is pregnant or nursing. 2. patient is morbidly obese or has other clinical conditions that severely inhibit x-ray visualization of the aorta. 3. patient has connective disease. 4. patient is hypercoagulable. 5. patient has active systemic infection. 6. patient is less than 18 years old. 7. patient has less than a one-year life expectancy. 8. patient is unwilling or unable to return for follow-up visits.
interactive computer treatment for panic disorder

Conditions: Panic Disorder

Summary: this study will develop an interactive computer-based version of cognitive behavioral therapy (cbt) and compare its effectiveness to book-based cbt for the treatment of panic disorder.

panic disorder (pd) is a highly prevalent and debilitating condition. unfortunately, many people with pd go untreated because of the high cost and low availability of treatment. research shows that cbt is an effective treatment for pd. when administered as a self-help, computer based treatment, cbt may provide a less expensive, more engaging treatment for pd. participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks. after these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of panic disorder, with or without agoraphobia exclusion criteria: * change in medication type or dose 12 weeks prior to study entry * suicidal * current substance abuse * current or past schizophrenia, bipolar disorder, or organic mental disorder. patients on medications must meet stability requirements such that initial administration of the medication and dose has been maintained for at least 3 months prior to treatment and will be maintained until post-treatment.
skin biophysical measures for assessing head and neck cancer-related external lymphedema

Conditions: Lymphedema, Secondary

Summary: selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

skin tissue dielectric constant (tdc) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area. measurements are made with subjects fully clothed and seated. measurements are made in triplicate and averaged at each site. full measurements take about 5-7 minutest to complete. data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Eligibility criteria:
inclusion criteria: * healthy with no current or past skin conditions affecting neck or arms exclusion criteria: 1. known to have diabetes of any type. 2. having facial or neck hair that prohibits accurate measurements

Keywords: tissue dielectric constant head and neck lymphedema lymphedema reference values
autologous adipose derived mscs transplantation in patient with spinal cord injury.

Conditions: Spinal Cord Injury

Summary: this study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

adipose derived mesenchymal stem cells (admscs) represent an attractive and ethical cell source for stem cell therapy. with the recent demonstration of msc homing properties, intravenous aplications of mscs to cell-damaged diseases have increased. in a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hadmscs (4×10e8 cells) one time.

Eligibility criteria:
inclusion criteria: * subjects who understand and sign the consent form for this study. * age :19-60, males * clinical diagnosis of spinal cord injury(american spinal injury association\[asia\] impairment scale\[ais\] grade a or b or c) * duration of injury : \> 2 months exclusion criteria: * subjects who must put on a respirator * subjects who had malignant tumor within 5 years * subjects with a infectious disease include hiv and hepatitis * subjects who injured brain or spinal cord before spinal cord injury * subjects who has high body temperature more than 38℃ or acute disorder * subjects with anemia or thrombocytopenia * subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease * subjects with congenital or acquired immunodeficiency disorders * subjects with muscular dystrophy or articular rigidity * patients with clouded consciousness or speech disorder * treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials * participating another clinical trials within 3 months * other serious disease or disorder that could seriously affect ability to participate in the study
alendronate in juvenile osteoporosis

Conditions: Juvenile Osteoporosis; Low Bone Density; Fractures

Summary: the investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (fosamax) for 12 months increased the bone density without side effects. in an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin d) increased only minimally. these trials were completed. thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. no treatment is involved.

with the availability of dual energy x-ray absorptiometry (dxa), juvenile osteoporosis has been recognized and diagnosed in recent years. the disease results from either diminished bone formation or increased bone removal (resorption) resulting in low bone density and fractures. no specific drug therapy has been recommended for juvenile osteoporosis. in an open label study, we earlier have shown that alendronate treatment (10 patients) for 12 months increased bone density without side effects. subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin d), increased the bone density only minimally. there were no side effects. these patients were treated with alendronate only for 12 months and the clinical trials have been completed. we therefore, have designed a post study to evaluate the current status of the bone density and fracture history in the above participants after the discontinuation (1-6 years) of alendronate treatment. available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. measurements include dxa bone density measurement of spine and hip, urinalysis and blood work. no treatment is involved.

Eligibility criteria:
inclusion criteria: * participated in our earlier clinical study; * completed the earlier open label or double blind study; * availability to participate in the post study; * male and female children who have earlier participated in our clinical trial; and * parental consent (and patient assent after age 12 years) to participate in the study. participant's consent for those who have completed 18 years of age and above at the time of clinic visit. exclusion criteria: * not participated in our earlier clinical study; * not completed our earlier trials; or * pregnancy.

Keywords: juvenile osteoporosis bone mineral density fosamax dual energy x-ray absorptiometry fracture
extravalvular procedure for surgical treatment of ascending aorta aneurism

Conditions: Ascending Aorta Aneurism; Aortic Insufficiency

Summary: the investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.


Eligibility criteria:
inclusion criteria: 1. aortic insufficiency 2+ 2. ascending aorta size more than 5 cm 3. ascending aorta size more than 4,5 cm (marfan syndrome) 4. good conditions of aortic cusps exclusion criteria: 1. aortic annulus more than 30 mm 2. aortic cusps destruction 3. critical aortic cusps elongation 4. aortic root dissection

Keywords: ascending aorta aneurism aortic insufficiency